MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE FLOW VALVULOPLASTY PERFUSION CATHETER; BALLOON VALVULOPLASTY CATHETER

Catalog Number TF0203511

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No medical records have been made available to the manufacturer.As the lot number for the device has not been provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.A photo was provided and is being reviewed.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that during a transcatheter aortic valve replacement, the valvuloplasty balloon allegedly ruptured at 14 atm's in an attempt to break the previously implanted surgical valve.Access was gained in the common femoral artery.The health care provider successfully implanted a corevalve to complete the procedure.There was no reported retraction issues.The patient was reported to be in stable condition.

Manufacturer Narrative

Manufacturing review: a lot history review could not be performed as the lot number is unknown.Visual/microscopic inspection: as the sample was not returned for evaluation, a visual/microscopic inspection could not be performed.Functional/performance evaluation: as the sample was not returned for evaluation, a functional/performance evaluation could not be performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: one electronic photo was reviewed by field assurance engineer.The photo shows a true flow valvuloplasty balloon.The balloon jacket appears peeled and bunched near the distal tip of the device.It is likely the user peeled back the jacket to identify and capture (photograph) the location of the rupture, as no peeling or retraction issues were reported by the user.The location or nature of the rupture cannot be identified.Based on the photo provided, the investigation cannot be confirmed for balloon rupture.Conclusion: the sample was not returned for evaluation, but a photo was submitted for review.The investigation is inconclusive for material rupture, as the sample was not returned and a rupture cannot be identified on the submitted photo.Per the reported event details, the catheter shaft burst at 14atm.The rated burst pressure (rbp) for this balloon size is 6atm; therefore, the balloon was overpressurized.The current instructions for use (ifu) states "do not exceed the rbp recommended for this device.Balloon rupture or difficulty in deflation may occur if the rbp rating is exceeded.To prevent over pressurization, use of a pressure monitoring device is recommended." the root cause for this event is user-related.Labeling review: the current instructions for use (ifu) states: warnings: - do not exceed the rbp recommended for this device.Balloon rupture may occur if the rbp rating is exceeded.To prevent over-pressurization, use of a pressure monitoring device is recommended.- when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or balloon separation, or cause injury to the patient (such as vessel perforation).Precautions: - if resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon.- in the very unlikely event of balloon burst or rupture, balloon could be more difficult to remove through the sheath and could require introducer sheath removal.Use of the true¿ flow valvuloplasty perfusion catheter: - position the balloon within the relevant area of the aortic valve to be dilated, ensure the guidewire is in place, and while ensuring the balloon is held in a static position, inflate the balloon to a pressure not greater than rbp.- apply negative pressure to fully evacuate fluid from the balloon.Confirm that the balloon is fully deflated under fluoroscopy.If balloon does not appear to be fully deflated, ensure product is outside aortic valve in safe position for secondary inflation.Inflate slightly and deflate again to ensure complete deflation is achieved.- while maintaining negative pressure and the position of the guidewire, withdraw deflated catheter over the guidewire and through the introducer sheath.Use of a gentle clockwise twisting motion ay be used to help facilitate catheter removal through the introducer sheath.- if unusual resistance is met when attempting to withdraw balloon, position balloon in anatomical position in which it can e inflated safely.Inflate balloon and then deflate it.Balloon re-folding can be observed under fluoroscopy.Use of recommended contrast concentration will facilitate fluoroscopic visualization of balloon re-folding.Equipment for use: - luer lock syringe/inflation device with manometer (50ml or larger).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that during a transcatheter aortic valve replacement, the valvuloplasty balloon allegedly ruptured at 14 atm's in an attempt to break the previously implanted surgical valve.Access was gained in the common femoral artery.The health care provider successfully implanted a corevalve to complete the procedure.There was no reported retraction issues.The patient was reported to be in stable condition.

• Brand Name: TRUE FLOW VALVULOPLASTY PERFUSION CATHETER
• Type of Device: BALLOON VALVULOPLASTY CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6028845
• MDR Text Key: 57402631
• Report Number: 2020394-2016-00961
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TF0203511
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 69